On February 10, 2022 Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension and, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, reported financial results for its third fiscal quarter ended December 31, 2021 (Press release, Beyond Air, FEB 10, 2022, View Source [SID1234608032]).
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Steve Lisi, Chairman and Chief Executive Officer of Beyond Air, commented, "The Beyond Air team continues to maintain a collaborative relationship with FDA to work towards the approval of LungFit PH for the treatment of persistent pulmonary hypertension of the newborn, or PPHN, in the United States. Our goal remains to bring this groundbreaking therapy to the market as soon as possible, which we now anticipate being in the first half of this year. With our strong cash balance of $54.5 million, exclusive of Beyond Cancer cash, we are in a favorable position for commercial launch of LungFit PH, pending approval. In Europe, we are on track to receive CE Mark in the first half of calendar year 2022 as well and will look to partner the program internationally later in the year."
"I am happy to report progress in our other programs under the leadership of our new Chief Medical Officer, Dr. Andrew Colin," continued Mr. Lisi. "Notably, we will be presenting additional safety and efficacy data from our community-acquired viral pneumonia (CAVP), including COVID-19, pilot study at ECCMID in April of this year. Recall, we presented an interim analysis of 19 COVID-19 patients at ATS 2021 in May, where 150 PPM NO was well tolerated and showed encouraging efficacy signals in adult hospitalized patients. Despite COVID-related lockdowns in Australia, we expect to present efficacy and safety data from our NTM pilot study using LungFit GO to deliver up to 250 ppm NO in the home setting at the American Thoracic Society conference in May of this year. Finally, our private oncology affiliate is on track to begin enrolling patients for a first in human study for UNO therapy in solid tumors in the first half of this year."
Recent Highlights and Upcoming Milestones
•LungFit PH
•Commercial launch for PPHN in the United States expected in the first half of calendar year 2022, pending U.S. FDA PMA approval
•CE Mark approval anticipated in the first half of calendar year 2022 with an international commercial partnership expected to follow later in the year
•LungFit PRO
Community-Acquired Viral Pneumonia (CAVP) Data (including COVID-19)
•Abstract for ongoing pilot study for 150 PPM NO delivered to adult hospitalized CAVP patients accepted for presentation at the 32nd European Congress of Clinical Microbiology and Infectious Disease being held April 23 – 26, 2022 in Lisbon, Portugal
Upcoming Study
•Plan on initiating a US trial for patients hospitalized with viral lung infections in the fourth quarter of calendar year 2022 (pending discussion with FDA and pandemic permitting)
•LungFit GO
•Abstract for ongoing pilot study for 250 PPM NO self-administered by refractory NTM lung infection patients in the home-setting accepted for presentation at the American Thoracic Society (ATS) 2022 International Conference being held from May 13 – 18, 2022 in San Francisco, CA
•Anticipate beginning a pilot study in severe exacerbations due to lung infections in COPD patients in 2022 or 2023
•Beyond Cancer’s Solid Tumor Program
•Raised $30 million to form private oncology affiliate Beyond Cancer that will leverage Beyond Air’s NO experience and accelerate and enhance the solid tumor pipeline. Beyond Air retained an 80% equity ownership
•On track to begin the enrollment of patients in first in human studies in the first half of calendar year 2022
•Two abstracts accepted for poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 in New Orleans, Louisiana being held from April 8 – 13, 2022
•Completed six-member Board of Directors with the agreement to serve of David C. Dvorak, former President and CEO of Zimmer Biomet Holdings and current Chairman and CEO of Deep Think Health, and Dr. Greg Berk, currently serving as the Interim CEO, President of Research & Development and CMO of GT Biopharma
Financial results for the fiscal quarter ended December 31, 2021
Revenue for the fiscal quarter ended December 31, 2021 was $0 as compared to $0.1 million for the fiscal quarter ended December 31, 2020, all of which was licensing revenue.
Research and development expenses for the fiscal quarter ended December 31, 2021 were $2.5 million, compared to $3.3 million for the fiscal quarter ended December 31, 2020.
General and administrative expenses for the fiscal quarter ended December 31, 2021 were $4.9 million, compared to $2.5 million for the fiscal quarter ended December 31, 2020.
Other income and expense for the fiscal quarter ended December 31, 2021 was a loss of $0.5 million.
For the fiscal quarter ended December 31, 2021, the Company had a net loss of $8.0 million of which $7.7m or ($0.29) per share was attributable to the shareholders of Beyond Air, compared to a net loss of $5.8 million, or ($0.33) per share for the fiscal quarter ended December 31, 2020.
As of December 31, 2021, the Company had cash and cash equivalents of $83.5 million.